AstraZeneca Plc has finally got clearance from the US government over a major clinical trial involving its new heart drug Brilinta. The company can now easily roll out the new drug into the market.
In a statement, AstraZeneca said that the US Department of Justice (DoJ) has decided to close the investigation into the study involving 18,000-patient and no further action was planned. With the decision, a major cloud over the UK drug maker’s outlook has been removed.
The new drug Brilinta, which is aimed at treating health problems, has the potential to become 3.5 billion dollar per year seller.
Earlier reports have suggested that the Department of Justice has raised questions against the clinical trials conducted by the company, saying it has raised several concerns over the drug’s medical value.
AstraZeneca Plc conducted a PLATO study for Brilinta and reported its results at a medical conference in 2009. The results pronounced it a successful new drug and this laid the basis of its application across the US, Europe and other markets. The heart drug was introduced into the market in 2011.
Soon after its launch, various elements of the study became the matter of criticism from medical experts. The study relied extensively on patients from Eastern Europe and this raised concerns among the experts.
Doctors James DiNicolantonio and Ales Tomek, who were from Ithaca in New York and Charles University in Prague respectively, raised their doubts over the methodology of the study and its participants. They conducted an investigation into the study and found that patients in PLATO trial who were observed by AstraZeneca had more beneficial effects from Brilinta as compared to the patients who were monitored by an autonomous clinical research institute.
With the new approval, AstraZeneca can now easily market the heart drug in the US market. Brilinta reported 216 million dollars modest sales in the first half of 2014.